Status:
COMPLETED
Allo BMT Using Matched Related/Unrelated Donors With FluBu and HiCY
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
M.D. Anderson Cancer Center
Fred Hutchinson Cancer Center
Conditions:
Lymphoma
Multiple Myeloma
Eligibility:
All Genders
Up to 65 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this research is to find the most effective and least toxic way to prevent GVHD after BMT.
Detailed Description
A person who has cancer of the blood or lymph glands can be treated by bone marrow transplantation (BMT). BMT has developed over several decades of research on both animal and human subjects as an eff...
Eligibility Criteria
Inclusion
- Patients ages between 0 to and 65 years of age.
- Patient must have a genotypically HLA-identical sibling, a phenotypically matched first-degree relative or an unrelated matched donor.
- Acute lymphocytic leukemia (ALL) in CR1 with high risk features
- Acute myeloid leukemia (AML) in CR1 with high risk features defined as:
- i. Greater than 1 cycle of induction therapy required to achieve remission, ii. Preceding myelodysplastic syndrome (MDS) other than myelofibrosis, secondary AML iii. Presence of Flt3 mutations or internal tandem duplications, iv. FAB M6 or M7 classification or adverse cytogenetics for overall survival such as those associated with MDS, M6, M7 leukemia, or v. Complex karyotype \[\> 3 abnormalities\]
- Acute Leukemias in 2nd or greater remission
- Refractory or Relapsed AML
- AML transformed from MDS
- Myelodysplastic syndrome (MDS) beyond refractory anemia
- Chronic myeloid leukemia (CML)
- Chronic myelomonocytic leukemia
- Philadelphia-negative myeloproliferative disorder
- Relapsed chemotherapy-sensitive Hodgkin's or Non-Hodgkin's lymphoma
- Multiple Myeloma-Stage III
Exclusion
- Prior autologous or allogeneic stem cell transplant.
- Performance status greater than 2
- Active infection.
- Inadequate cardiac function; arrythmias or symptomatic cardiac disease.
- Inadequate pulmonary function; FEV1, FVC, DLCO \<50% of predicted
- Inadequate Serum creatinine clearance \<60
- InadequatebHepatic function
- Positive serology for HIV-1, 2 or HTLV-1, 2.
- Pregnancy. Female patient must have negative pregnancy test
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT00809276
Start Date
May 1 2009
End Date
December 1 2011
Last Update
February 16 2015
Active Locations (3)
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1
The Sydney Kimmel Comprehensive Cancer center
Baltimore, Maryland, United States, 21231
2
Marcos deLima, MD
Houston, Texas, United States, 77030
3
Paul V. O'Donnell, M.D., Ph.D.
Seattle, Washington, United States, 98109